External Reader for Device Management

ABSTRACT

A system for tracking use of a medical device including an electrosurgical generator, a readable module and a read module. The electrosurgical generator is configured to selectively deliver an electrosurgical energy signal to an electrosurgical delivery device connected to the electrosurgical generator. The readable module is connected to the electrosurgical delivery device and configured to uniquely identify the electrosurgical delivery device. The read module is in communication with the electrosurgical generator that identifies the read module, the read module configured to identify the readable module and further configured to determine the viability of the electrosurgical delivery device. Delivery of electrosurgical energy to the electrosurgical delivery device is enabled by the read module if the electrosurgical delivery device is a viable device.

BACKGROUND

1. Technical Field

The present invention relates to systems and methods for performing amedical procedure, wherein the systems and methods record and tract theusage of single use and reusable medical devices.

2. Description of Related Art

The use of electrosurgical instruments is well known in the art.Electrosurgical instruments typically utilize both mechanical clampingaction and electrical energy to affect hemostasis by heating the tissueand blood vessels to coagulate, cauterize and/or seal tissue. Over thecourse of a surgical procedures a clinician may use a variety ofelectrosurgical instruments such as, for example, elongatedelectrosurgical forceps to cauterize, coagulate/desiccate and/or tosimply reduce or slow bleeding in a surgical cavity, electrosurgicalpencil or scalpel for cutting or to cauterize a surgical opening, anelectrosurgical vessel sealing device including actuating jaw members ofan end effector assembly for sealing and cutting vessels. In addition tothe assortment of electrosurgical instruments available to a clinician,many electrosurgical instruments are configured to receive a variety ofattachments or members, such as tips, jaws, blades, electrodeconfigurations or combination thereof.

During the course of a surgical procedure, a clinician may employ avariety of different instrumentation, including reusable instruments,limited use reusable instruments, and disposables instrument. Reusableinstruments are instruments where the reusability of the instrument islimited only by operability of the instruments (e.g., proper operation,recommended maintenance and/or reconditioning schedules). A limited usereusable instrument includes instruments with a limited useful life,wherein the useful life of the instrument may be based the number ofelectrical activations, the cumulative time of electrical activation,the number of mechanical activations, the number of surgical proceduresperformed or any combination thereof. A disposable instrument is aninstrument intended to be introduced to a surgical field, used for itsintended purpose and immediately disposed of thereafter.

Instruments may also be configured to receive a disposable or limiteduse attachment or member. For example, a reusable electrosurgicalscalpel may be configured to receive a limited use or disposable bladeor a limited use reusable vessel sealing device may be configured toreceive a disposable single-use shaft and end effector or end effectorassembly or jaw assembly.

A manufactures' “limited use” or “disposable” recommendation istypically based on performance testing, reliability testing, theinability to properly sterilize the instrument or attachment memberusing conventional sterilizing techniques, the material degradation as aresult of conventional sterilization techniques or any combinationthereof. A clinician must know the use limitation, track the actualusage and abide by the instructions by disposing of the instrument afterthe actual usage has been exceeded. In some instances there may be atemptation to re-use disposable instruments or use items beyond therecommended useful life to save costs especially in clinic-typeenvironments or low-income areas. Obviously, health issues and concernsarise when disposable instruments are re-used for surgical purposes orwhen instruments are used beyond their recommended life or cycles. Assuch, the use recommendation for reusable or disposable memberssometimes depends on the clinician, surgeon or surgical personnel todiscard the instrument or member after the manufactures' recommendednumber of uses is exceeded.

To assist clinicians in abiding by a manufacturer's intended use anddisposal instructions, and to prevent intentional re-use of instruments,manufactures have employed a number of systems and methods. For example,to prevent accidental reuse, some instruments are packaged such that thepackaging is destroyed when opened. Other instruments employsmart-connectors to prevent reconnection and reuse of a particularinstrument with the same electrosurgical generator. Other instrumentshave employed a time-out device configured to prevent re-use of theelectrosurgical instrument after a pre-determined time limit.

The present disclosure describes devices and systems that interface withan existing electrosurgical generator, or the like, to record and trackthe usage of single use and reusable medical devices.

SUMMARY

The present disclosure relates to a system for tracking use of a medicaldevice, including an electrosurgical generator configured to selectivelydeliver an electrosurgical energy signal, an electrosurgical deliverydevice configured to connects to the electrosurgical generator andreceives the electrosurgical energy signal therefrom, a readable moduleconnected to the electrosurgical delivery device and configured touniquely identify the electrosurgical delivery device; a read module incommunication with the electrosurgical generator and configured toidentify the read module, the read module configured to identify thereadable module and further configured to determine the viability of theelectrosurgical delivery device, wherein delivery of the electrosurgicalenergy to the electrosurgical delivery device is enabled by the readmodule if the electrosurgical delivery device is a viable device.

Another aspect of the system includes a device tracking and managementsystem in communication with the read module and configured to provideinformation specific to the uniquely identified electrosurgical deliverydevice to the read module. The read module may determine the viabilityof the electrosurgical delivery device based on the information specificto the uniquely identified electrosurgical delivery device provided fromthe device tracking and management system. The read module may provideinformation relating to the electrosurgical generator to the devicetracking and management system. The device tracking and managementsystem may include a billing module configured to generate a per usebill based on the information related to the electrosurgical generatorprovided by the read module. The device tracking and management systemmay includes an inventory control module configured to maintain productinventory based on the information related to the electrosurgicalgenerator provided by the read module.

According to a further aspects of the disclosure, the readable moduleincludes a bar code, and the read module includes a scanner configuredto identify the bar code. The readable module may also include a radiofrequency identification module and the read module may also include ascanner configured to identify the radio frequency identificationmodule.

According to other aspects of the disclosure, the readable moduleincludes a readable module wireless communication device and the readmodule includes a read module wireless communication device configuredto wirelessly communicate with the readable module wirelesscommunication device. The readable module may also include memoryaccessible by the read module when the read module electrically connectsto the memory.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described hereinbelow withreference to the drawings, wherein:

FIG. 1 is a perspective view of an electrosurgical system utilizing anexternal usage tracking system according to an embodiment of the presentdisclosure;

FIG. 2A is a perspective view of the packaging readable module;

FIGS. 2B and 2C are perspective views of packaging readable modulesrendered inoperable by exposure to ambient conditions;

FIG. 2D is a perspective view of the packaging readable module renderedinoperable by separating the bottom layer and the top layer of thepackaging materials; and

FIG. 2E is a perspective view of the packaging readable module with aportion of the packaging readable module formed on the bottom layer anda portion of the readable module formed on the top layer of thepackaging materials.

DETAILED DESCRIPTION

Detailed embodiments of the present disclosure are described herein;however, it is to be understood that the disclosed embodiments aremerely exemplary and may be embodied in various forms. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one skilled in the art to employ thepresent disclosure in virtually any appropriately detailed structure.

In the drawings and in the descriptions that follow, the term“proximal,” as is traditional, will refer to an end which is closer tothe user, while the term “distal” will refer to an end that is fartherfrom the user.

Generally, the systems and methods described herein are related to anexternal usage tracking system that includes a readable module and oneor more read modules for preventing and/or tracking use of a reusableand/or disposable instrument. A read module is associated with aninstrument and may be incorporated into, and/or affixed to, aninstrument, the packaging of the instrument or both. The read moduleinterfaces with each readable module and receives one or moreidentifying characteristic of the associated instrument from the readmodule. The identifying characteristics are used to determine theviability of the instrument and read module provides the viability ofthe instrument to a system that interconnects and/or interfaces with theinstrument. The viability of the instrument may be related to systemcompatibility and/or connectability, related to a prior use, related toan expiration date and/or timeframe, or related to any other suitablemeasure or criteria.

Referring now to FIG. 1, an electrosurgical system for supplyingelectrosurgical energy for a medical procedure including an externalusage tracking system 100 according to an embodiment of the presentdisclosure, is shown as 10. The electrosurgical system 10 includes anelectrosurgical generator 20, a delivery device 30 configured to coupleto the electrosurgical generator 20 via a transmission line 34 and anexternal usage tracking system 100.

The electrosurgical system 10 is provided and described to demonstratethe use and features of an external usage tracking system 100. Thisspecific example should not be construed as limiting. The external usagetracking system 100 may be used with any system that utilizes disposableand/or limited use components such as, for example, systems that utilizedisposable end effectors (e.g., radiofrequency systems, microwavesystems and/or ultrasonic systems), and systems that utilize disposablecartridges (power-staplers, printers, copiers, power nail driver, and/ora CO2 cartridge actuated device).

Electrosurgical generator 20 may include an operator interface 40 havinga keypad 42 for entering parameters related to electrosurgical generator20, the delivery device 30 and/or parameters related to the operationthereof. Display 44 may indicate or graph one or more parameters relatedto the surgical procedure, the electrosurgical generator 20, thetransmission line 34 and/or delivery device 30 and/or the external usagetracking system 100. Electrosurgical generator 20 includes a centralprocessing unit and control circuit (not explicitly shown) forcontrolling the operation of the electrosurgical generator 20.

Delivery device 30 may be any suitable electrosurgical delivery devicesuch as, for example, a radio-frequency, microwave, and/or ultrasonicablation device, a tissue-sealing device or other electrosurgical tissuetreatment device, or delivery device 30 may be a component deliverydevice such as a power-stapler, power-nail driver, printer or copier.Delivery device 30 may be a single-use disposable device, a multi-usedisposable device or a limited use reusable device.

Transmission line 34 may be a coaxial cable (i.e., a waveguide), amulti-conductor cable or any other suitable cable or combination thereoffor transmitting an electrosurgical energy signal and/or electrosurgicalcontrol signals. Connector 24 disposed on the proximal end of thetransmission line 34 couples to a transmission line receiver 46 on theelectrosurgical generator 20. A distal end of the transmission line 34connects to the handpiece 36 of the delivery device 30.

External usage tracking system 100 includes a read module 110, one ormore readable modules 120 and a remotely-located device tracking andmanagement system 115. The various components of the external usagetracking system 100 cooperate to track and record the usage of eachspecific delivery device 30 as described hereinbelow.

Read module 110, as illustrated in FIG. 1, connects directly to theelectrosurgical generator 20 through a read module cable 112. The readmodule cable 112 may connect directly to a preexisting communicationport 46 b in the electrosurgical generator 20 and may use any suitablecommunication protocol to communicate with the electrosurgical generator20. Alternatively, read module 110 may connect to an analog or digitalinput port on the electrosurgical generator 20 and may provide an analogor digital signal that provides information and/or data related to orfrom the external usage tracking system 100. One suitable communicationprotocol may include a wireless protocol (e.g., Wi-Fi, Bluetooth, ZigBeeor other suitable wireless communication protocol) wherein the readmodule 110 wirelessly connects to the electrosurgical generator 20.

In some embodiments, the read module 110 is a smart device configured toexecute one or more applications related to the external usage trackingsystem 100. The one or more applications may be related to controlling ascanner housed in the read module 100 and configured to read/identify areadable code formed by the readable module 120. For example, oneapplication may control an optical reading device (e.g., camera/bar codescanner) configured to identify/read the readable code. The readablecode may be a one-dimensional bar code, a two-dimensional bar code orany optically distinguishable and/or identifiable pattern. A readablecode and a bar code may be used interchangeably herein. Read module 110,in addition to communicating with the device tracking and managementsystem 115, may include an application configured to communicate withindividual read modules 110 thereby forming a localized network betweenpluralities of read modules 110. In some embodiments, read module 110 isa wireless pistol grip reader.

In another embodiment, the read module 110 functionality describedherein is incorporated into the circuitry of a new electrosurgicalgenerator 20. As such, the particulars of the electrosurgical generator20, delivery device 30 and external usage tracking system 100, and theinteraction of the various components illustrated in the figures anddescribed herein, may be distributed between the electrosurgicalgenerator 20, the delivery device 30 and other components of theexternal usage tracking system 100. As such, the system and methodsdescribed herein are provided only as examples and should not beconstrued as limiting.

Read module 110 is configured to interface with one or more readablemodules 120 associated with a specific delivery device 30. Readablemodules 120 are read and/or detected by the read module 110 and mayinclude any suitable readable and/or detectable technologies. Forexample, readable module 120 may include a readable identification codesuch as, for example, a one-dimensional bar code 120 a, atwo-dimensional bar code 120 b or any other suitable readableidentification pattern, device or coding.

Readable module 120 may also include a hard-wired readable technologysuch as, for example, an EEPROM, microcontroller or smart card 120 e.Read module 110 may connect to the readable module 120 by a suitableelectrical cable (not explicitly shown) or readable module (e.g., smartcard 120 e) may be removed from the delivery device 30 and connected tothe read module 110. Information related to the delivery device 30 istransferred between the read module 110 and the readable module 120 viathe readable module (e.g., smart card 120 e).

Readable module 120 may also connect to the read module 110 via awireless communication system (e.g., wireless transmitter/receiver 120c). Wireless transmitter/receiver 120 c may connect by any suitablelow-power wireless digital communication protocols, such as, forexample, Bluetooth or ZigBee. Read module 110 may be configured toautomatic detect a delivery device 30 with a wirelesstransmitter/receiver 120 c when a delivery device 30 is positionedproximate to the read module 110. Alternatively, a wireless connectionmay be manually initiated by a clinician.

Readable module 120 may also connect to the read module 110 via adetectable technology such as, for example, a radio frequencyidentification device (RFID) 120 d. Read module 110 may detect thereadable RFID module 120 d positioned on (or within) the delivery device30 after the delivery device 30 is positioned proximate the read module110. The readable RFID module 120 d connected to the delivery device 30may be automatically detected the by the read module 110 or detectionthereof may be manually initiated by a clinician.

In use, the read module 110 receives identification information from oneor more readable modules 120 a-120 e positioned on a specific deliverydevice 30 or positioned on the packaging material 130 that house thedelivery device 30. The read module 110 connects to the device trackingand management system 115 via a direct or indirect connection (e.g., awi-fi or wireless connection) and provides the identificationinformation thereto.

The device tracking and management system 115 utilizes theidentification information to locate tracking and usage informationrelated to the specific delivery device 30. The tracking and usageinformation is used to determine if the specific delivery device 30 is aviable device (e.g., reusable and/or unused device), a compatible device(e.g., compatible to the specific electrosurgical generator 20) and/or adevice that is safe to use (e.g., no manufacturing recalls). Thedetermination step may be performed by the device tracking andmanagement system 115, the read module 110, the electrosurgicalgenerator 20 or any combination thereof.

New information (or changes to existing information) may be related tothe use of the electrosurgical generator 20 with the specific deliverydevice 30. The new information, or changes to the existing information,may be added to the corresponding record in the device tracking andmanagement system 115 before, during and/or after the delivery device 30is used. The information may include time-stamped information,information related to the electrosurgical generator 20, read module 110and readable module 120, information related to the surgical procedure(e.g., type, duration, etc. . . . ), information related to performanceand/or delivered energy and information related to the user and/orfacility (e.g., an operator entered facility code or location codes).

Device tracking and management system 115 tracks one or more aspects ofa specific delivery device 30. For example, device tracking andmanagement system 115 may track the usage of a single-use deliverydevice and may further prevent the re-use of the single-use deliverydevices 30. Device tracking and management system 115 may also track theuse and reuse of a specific reusable delivery device 30 and may preventre-use of the specific reusable delivery device 30 if the specific useis determined to be an unsafe or not permitted. Device tracking andmanagement system 115 identifies each specific delivery device 30 duringor after manufacturing, associates the readable devices 120 with thespecific delivery device 30, tracks each specific delivery device 30throughout its usable life, and prevents reuse after the usable life hasexpired.

Device tracking and management system 115 may also be configured toinclude the functionality of an enterprise resource planning system. Forexample, a component of the device tracking and management system 115may include an inventory control module 115 a for tracking andcontrolling inventory for a specific office, hospital and/or a specificstorage location therein. Inventory control module 115 a of the devicetracking and management system 115 may automatically generate ordersbased on usage and/or availability or may provide order recommendationsbased on historic usage.

Device tracking and management system 115 may also include asterilization control module 115 b to provide sterilization monitoringand tracking. In some embodiments, sterilization control module 115 b ofthe device tracking and management system 115 tracks, records and/ormonitors each individual use and subsequent sterilizations that occurafter each of the uses. Device tracking and management system 115 mayprevent a specific delivery device 30 from re-entering an inventorysystem if time-stamp information indicates that sterilization was notperformed, indicates with a high degree of likelihood that sterilizationwas not adequately performed or indicates that sterilization wasbypassed altogether. For example, time-stamp information from theelectrosurgical generator 20 may indicate that a specific deliverydevice 30 was being reintroduced into inventory directly after anindicated use, thereby indicating that sterilization could not have beenperformed.

Device tracking and management system 115 may also include a billingmodule 115 c that generates automated customer billing (for single useand/or limited-use reusable delivery devices) and/or automated patientbilling (for single use devices, pay-per-use devices and/or splitbilling for pay-per-use or reusable devices). For example, in a surgicalprocedure a read module 110 identifies a specific delivery device 30 andreports the use to the device tracking and management system 115. If thespecific delivery device 30 is a single use device, the inventorycontrol module 115 a would initiate a reorder for a new delivery deviceand the billing module 115 c would initiate appropriate patient billingfor use of the delivery device 30. If the specific delivery device 30 isa limited use reusable device, the inventory control module 115 a mayinitiate a reorder of the delivery device 30 if the use trackingindicates the delivery device 30 has expired and the delivery device 30can not be reused. The billing module 115 c generates appropriatepatient billing for the allocated percentage of use of the deliverydevice 30 and an order may be initiated by the inventory control module115 a.

External usage tracking system 100 is configured to interface with theelectrosurgical control algorithm that controls the operation of theelectrosurgical generator 20. In some embodiments, the electrosurgicalcontrol algorithm in an existing electrosurgical generator 20 isreprogrammed to connect to the read module 110 through a pre-existingcommunication port 46 b. As such, implementation of an external usagetracking system 100 may be accomplished by implementing a softwareupgrade of the electrosurgical control algorithm in an existingelectrosurgical generator 20 and connecting the read module 110 to theelectrosurgical generator 20.

New electrosurgical generators may be configured to connect to a readmodule 110 of the external usage tracking system 100 through anysuitable wireless personal area network (WPAN) such as, for example,Bluetooth, infrared or WiFi, therefore requiring minimal changes toimplement an external usage tracking system 100.

The information provided to the electrosurgical generator 20 from theread module 110 may include information related to the manufacturing,assembly and testing of the delivery device 30, information related touse of the delivery device 30 and/or information related to thecompatibility of the delivery device 30 with the electrosurgicalgenerator 20. The information may also be related to the safe operationof the delivery device 30 and may include safe operating procedures,product recall information and/or information about the delivery device30 and/or materials used to manufacture the delivery device 30 that wereobtained after the delivery device 30 was manufactured.

The external usage tracking system 100 may provide the read module 110with product performance information related to the specific deliverydevice 30 such as delivery device 30 specifications and test data. Ascan be appreciated, identification of the specific delivery device 30 bythe external usage tracking system 100 provides the capability ofproviding up-to-date information related to the specific delivery device30.

In another embodiment, the information provided to the electrosurgicalgenerator 20 from the read module 110 may be limited to enabling and/ordisabling when the read module 110 and/or the device tracking andmanagement system 115 (or any component thereof) determines if thespecific delivery device 30 has expired. The read module 110 provides anenable/disable signal to the electrosurgical generator 20 whereinproviding an enable signal indicates that the delivery device 30 is aviable device (e.g., unused and/or capable of being reused), acompatible device, an unexpired device and/or any combination thereof.The enable signal may enable delivery of the electrosurgical energy tothe delivery device 30.

New delivery device platforms may include new features designed forconnecting and interfacing with new electrosurgical generators. As such,the new delivery device platforms are incompatible with the earlygeneration electrosurgical generators 20. For example, a new deliverydevice platform may include features related to an external usagetracking system 100 that had not been included in early generationelectrosurgical generators. As such, read module 110 may be configuredto interface with the features included in the new delivery devicesplatform (e.g., wireless communication transmitter/receiver 120 c aswill be discussed in more detail herein). As such, an electrosurgicalsystem 100 with an early generation electrosurgical generator 20 mayutilize the new platform features provided in or with a new deliverydevice 30 platform by interfacing with the early generationelectrosurgical generator 20 through the read module 110.

Returning to FIG. 1, the delivery device 30 is configured to interfacewith the external usage tracking system 100. Delivery device 30 includesa plurality of readable modules 120 configured to interface with thereadable module 110. FIG. 1 illustrates several readable modules 120although as few as one readable module 120 may be used.

In some embodiments, read module 120 is incorporated into the packagingmaterials 130 (e.g., one-dimensional bar code 120 a formed in thesoft-pack 130), incorporated into the connector 24 on the proximal endof the transmission line 34 (e.g., two-dimensional bar code 120 b),incorporated into the handle 36 of the delivery device 30 (e.g., RFID120 d or wireless communication transmitter/receiver 120 c) or anycombination thereof.

The delivery device 30 may include a readable RFID module 120 d. Thereadable RFID module 120 d may attach to the exterior of the deliverydevice 30 (e.g., on the housing 36), as illustrated in FIG. 1, or thereadable RFID module 120 d may be positioned in the interior cavityformed by the housing 36. The operation of the readable RFID module 120d and the external usage tracking system 100 may be independent of theoperation of the delivery device 30. As such, the readable RFID module120 d may be attached to an existing device (e.g., externallypositioned) or incorporated into the delivery device 30 during theassembly process (e.g., internally or externally positioned).

In another embodiment, the internal circuitry of the delivery device 30includes readable RFID circuitry (not explicitly shown). Internalcircuitry may provide data related to the use of the delivery device 30and send the data to the readable RFID circuitry (not explicitly shown)and the readable RFID circuitry provides at least a portion of the datarelated to the use of the delivery device 30 to the read module 110 ofthe external usage tracking system 100.

In use, the read module 110, when placed in suitable proximity to areadable RFID module 120 d, receives information from the readable RFIDmodule 120 d. The information may include identification informationthat directly identifies the delivery device 30 or that indirectlyidentifies the delivery device 30 through identification of the RFIDmodule 120 d. The information may direct the read module 110 to a table,database or other data storage location that contains identificationand/or usage information of the delivery device 30. For example, in someembodiments, the read module 110 receives identification informationrelated to the readable RFID module 120 d that directs the read module110 to a database entry containing information related to the specificdelivery device 30. The read module 110 may determine the compatibilitybetween the delivery device 30 and the electrosurgical generator 20thereby preventing use of an incompatible delivery device 30. The readmodule 110 may also determine if the delivery device 30 has beenpreviously used thereby preventing reuse of a disposable product. Inaddition, the read module 110 may determine if the use of a limited-usereusable delivery device 30 has exceeded a maximum number of usesthereby preventing overuse of a limited-use reusable product.

After detecting the readable RFID module 120 d, the read module 110 mayverify compatibility between the delivery device 30 and theelectrosurgical generator 20, may then determine various use parametersrelating to the delivery device 30 and provide a signal to enable ordisable the use of the electrosurgical generator 20 with the identifieddelivery device 30.

In some embodiments, the readable RFID module 120 d may be connected tothe energy delivery portion or control portion of the delivery device 30such that the readable RFID module 120 d is rendered inoperable orunreusable by the delivery device 30 when the delivery device 30connects to, or receives electrosurgical energy from, theelectrosurgical generator 20. For example, delivery device 30 may alterthe information stored on the readable RFID module 120 d or alter theoperation of the readable RFID module 120 d such that any attempt toreuse the delivery device 30 with the attached readable RFID module 120d would result in the external usage tracking system 100 detecting theprior use thereby preventing reuse of the delivery device 30.

Readable RFID module 120 d may also be susceptible to one or moreaspects of sterilization procedures. Exposure to a sterilization processalters information stored the readable RFID module 120 d or thesterilization process rendering the readable RFID module 120 dinoperable. For example, the readable RFID module 120 d may be sensitiveto heat, fluid, electromagnetic radiation and/or exposure to otherconditions related to a sterilization process such that any attempt toreuse the delivery device 30 with a readable RFID module 110 that hasbeen exposed to a sterilization process would result in detection by theexternal usage tracking system 100.

A packaging readable module 120 a, with functionality related toreadable modules 120 b-120 e discussed herein, may be incorporated intothe packaging material (e.g., soft-pack 130). Packaging readable module120 a may be provided as an alternative to the readable modules 120a-120 e positioned on the delivery device 30 or may be provided inaddition to one or more readable modules 120 a-120 e.

In another embodiment, the packaging readable module 120 a positioned onthe packaging material (e.g., soft-pack 130) corresponds to a readablemodule 120 b-120 e associated with the delivery device 30. Read module110 must identify the packaging readable module 120 a and acorresponding readable module 120 b-120 e positioned on the deliverydevice 30 prior to enabling the operation of the electrosurgicalgenerator 20.

The packaging readable module 120 a may include a one-dimensional barcode, as illustrated in FIG. 1, incorporated into the packaging material(e.g., soft-pack 130). Prior to opening the packaging materials (e.g.,soft-pack 130), the packaging readable module 120 a may be accessible(e.g., optically scanned and/or read) by the read module 110 through oneor more layers of the packaging material (e.g., soft-pack 130). Thepackaging readable module 120 a is positioned on the packaging material(e.g., soft-pack 130) such that the packaging readable module 120 a isdestroyed or rendered unreadable upon opening of the packaging material(e.g., soft-pack 130).

The packaging, packaging materials and packaging techniques describedherein and illustrated in the drawings should not be construed aslimiting as the teachings provided herein may be utilized with, orincorporated into, other suitable surgical packages. Soft-pack 130includes a flexible bottom layer 130 a and a flexible top layer 130 bconnected together by an adhesive seal 132 thereby forming a sterile,interior pocket 143 therebetween. An adhesive seal 132 positioned alongthe edge of the flexible bottom layer 130 a and the flexible top layer130 b along a first, second and third edges 131 a-131 c bonds the bottomlayer 130 a to the top layer 130 b. The position of the adhesive seal132 (e.g., inset from the fourth edge 131 d) provides access to theindividual layers of the soft-pack 130 (e.g., flexible bottom layer 130a and flexible top layer 130 b). The adhesive seal 132 formed adjacentthe first, second and third edges 131 a-131 c prevents separationbetween the flexible bottom and top layers 130 a and 130 b.

A read module 120 a, positioned between the fourth edge 131 d and theadhesive seal 132, is attached to the flexible top and bottom layers 130a and 130 b and readable by the reader module 110 through the flexiblebottom layer 130 a and/or the flexible top layer 130 b. The soft-pack130 is opened by separating the flexible top and bottom layers 130 a and130 b thereby breaking the adhesive seal 132 along the fourth edge 131d. Further separating the flexible top and bottom layers 130 a and 130 bbreaks at least a portion of the adhesive seal 132 along the first andsecond edges 131 a and 131 b.

A readable module 120 a, positioned between the flexible bottom and toplayers 130 a and 130 b along the fourth edge 131 d, includes a bondbetween the readable module 120 a and each of the bottom and top layers130 a and 130 b. The bond may be stronger than the material used toconstruct the readable module 120 a. For example, the readable module120 a may be adhesively attached to the bottom and top layers 130 a and130 b by an adhesive layer 131. The bond between the readable module 120a and each of the bottom and top layers 130 a and 130 b may besufficiently strong that separating the bottom and top layers rendersthe readable module 120 a non-functional (e.g., unreadable and/orunidentifiable by the read module 110).

In another embodiment, the readable module 120 a is formed by bondingtogether the bottom and top layers 130 a and 130 b. As illustrated inFIG. 2D, the bottom and top layers 130 a and 130 b are fused togetherthereby forming a single layer therebetween. As such, opening the softpack requires the destruction of the bond between the bottom and toplayers 130 a and 130 b thereby rendering the readable module 120 aunreadable (e.g., thereby tearing the two layers and/or stretching ofthe two layers thereby rendering the code unreadable).

In another embodiment, bottom and top layers 130 a and 130 b form afluid-tight seal around the readable module 120 a thereby isolating thereadable module 120 a from ambient conditions. Opening the soft-pack 130(e.g., removing the delivery device 30) exposes the readable module 120a to the ambient conditions thereby rendering the readable module 120 anon-functional and/or unreadable. For example, the readable module 120 amay be printed with an evaporative material that evaporates when exposedto ambient conditions, as illustrated in FIG. 2B. Alternatively, asillustrated in FIG. 2C, the readable module 120 a may include a reactivematerial that modifies the barcode pattern (e.g., changes the pattern ofthe barcode by eliminating a portion of the pattern, as illustrated inFIG. 2B, or by adding an additional portion to the pattern, asillustrated in FIG. 2C), thereby rendering the barcode unreadable.

In some embodiments, the reactive material forms at least a portion of areadable code and the reactive material reacts with one or morecomponents in air. For example, the readable code may be formed with asolution of thymolphthalein and a base material and then sealed betweenthe bottom and top layer 130 a and 130 b. When opened, the base reactswith carbon dioxide, which is always present in air, thereby droppingthe pH to a level where the readable code disappears thereby renderingthe packaging readable material inoperable.

In another embodiment, at least a portion of the readable codebackground is formed with a solution that becomes dark (e.g., reactswith air and/or oxidizes in the presents of air) when exposed to ambientconditions thereby modifying the structure of the readable code andrendering the packaging readable material inoperable.

In yet another embodiment, a first portion of the readable module 120 ais formed on the bottom layer 130 a and a second portion of the readablemodule 120 a is formed on the top layer as illustrated in FIG. 2E.Separation of the bottom layer 120 a from the top layer 130 a rendersthe readable module 120 a unreadable.

Other surgical instrument packaging arrangements may include half-shellpackaging. A half-shell instrument package includes a rigid orsemi-rigid bottom half-shell assembly containing at least one cavity forreceiving a surgical instrument and a flexible lid portion configured tocover the cavity. A half-shell instrument package may also include aplurality of spaced apart cavities for selectively plating protectiveplugs at each end of the implement such that one packaging cavity may beused for a plurality of variously sized instruments. Half-shell assemblytypically includes a flange area upon which the flexible lid portionadhesively attaches thereby forming a sterile cavity therebetween.

A readable module may be incorporated into the half-shell package suchthat separation of the flexible lid portion from the bottom half-shellassembly renders the readable module unreadable.

Yet another surgical instrument packaging arrangement includes afull-shell instrument package. A full-shell instrument package includesrigid top and bottom portions that connect in a plurality of locationsthereby forming a sterile cavity for the delivery device therebetween.This type of package may be a single use package or may be resealable,and therefore reusable.

In another embodiment, a reusable delivery device 30 includes tworeadable modules 120 that provide information related to the specificdelivery device 30. A first readable module (e.g., the packagingreadable module 120 a) is formed in the packaging material (e.g.,soft-pack 130) and a second readable module (e.g. one of readablemodules 120 b-120 e) is connected the reusable delivery device 30.

During the manufacturing and packaging process, the first readablemodule and the second readable module are provided with identificationinformation that identifies the specific reusable delivery device 30housed in the packaging materials.

The total use of the reusable delivery device 30 includes a first useand a finite number of subsequent permissible reuses with the finalpermissible use being the last permissible use.

In some embodiments, during the first use the clinician is required toidentify the delivery device 30 by reading/scanning the first readablemodule 120 a and the second readable module 120 b-120 e with the readmodule 110 of the external usage tracking system 100. The external usageand tracking system 100 determines that the delivery device 30 has notbeen previously used and thereby identifies the use as the first use.

The external usage and tracking system 100 may indicate an identifyingfeature related to the first use that further limits subsequent reusesof the delivery device 30. For example, the read module 110 may providea location indicator that attaches to the identification information ofthe specific delivery device 30. The location indicator may identify thesurgical facility, may identify a customer identifier, may identify abilling entity or any other information related to the specific user ofthe delivery device 30. The location indicator may further limit use ofthe specific delivery device 30 to systems and devices related to thelocation indicator.

In another embodiment, the packaging materials 130 may be configured forreuse with the delivery device 30. As such, each subsequent permissibleuse may require scanning/reading of the first readable module 120 a andthe second readable module 120 b-120 e prior to the subsequentpermissible use. The delivery device 30 may be reused until the externalusage and tracking system 100 determines that the current use is thelast use and thereafter the delivery device 30 will be unusable. Anysubsequent attempt to reuse the delivery device 30 will not be permittedby the external usage and tracking system 100.

In another embodiment, the packaging materials 130 are not reusable andintended to be discarded after the first use. As such, each subsequentpermissible use only requires scanning/reading of the second readablemodule 120 b-120 e. The delivery device 30 may be reused until theexternal usage and tracking system 100 determines that the current useis the last use and thereafter the delivery device 30 will be unusable.Any subsequent attempt to reuse the delivery device 30 will not bepermitted by the external usage and tracking system 100.

A subsequent scan of the first readable module 120 a would indicate thatpackaging materials 130 that were not intended for reuse were reused andmay indicate improper sterilization procedures. Reuse of the deliverydevice 30 may be prohibited or prevented. Alternatively, the rescanningof a first readable module 120 a on a subsequent permissible use maygenerate an indicator or alarm that proper sterilization procedures werenot performed at the identified location or performed by the identifieduser.

In yet another embodiment, the external usage and tracking system 100 asdescribed herein, is incorporated into a sterilization system. Forexample, the electrosurgical system 20, as illustrated in FIG. 1, may bea sterilization system 20 that sterilizes the delivery device andprepares the delivery device for a subsequent use as discussedhereinabove. The sterilization system 20 provides information related tothe sterilization of the delivery device, either directly or indirectlythrough read module 120, to the device tracking and management system115.

While several aspects of the disclosure have been shown in the drawings,it is not intended that the disclosure be limited thereto, as it isintended that the disclosure be as broad in scope as the art will allowand that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular aspects. Those skilled in the art willenvision other modifications within the scope and spirit of the claimsappended hereto.

What is claimed is:
 1. A system for tracking use of a medical device,comprising: an electrosurgical generator configured to selectivelydeliver an electrosurgical energy signal; an electrosurgical deliverydevice configured to connect to the electrosurgical generator andreceive an electrosurgical energy signal therefrom; a readable moduleconnected to the electrosurgical delivery device and configured touniquely identify the electrosurgical delivery device; and a read modulein communication with the electrosurgical generator that identifies theread module, the read module configured to identify the readable moduleand further configured to determine the viability of the electrosurgicaldelivery device; wherein delivery of the electrosurgical energy to theelectrosurgical delivery device is enabled by the read module if theelectrosurgical delivery device is a viable device.
 2. The systemaccording to claim 1, further including: a device tracking andmanagement system in communication with the read module and configuredto provide information specific to the uniquely identifiedelectrosurgical delivery device to the read module, wherein the readmodule determines the viability of the electrosurgical delivery devicebased on the information specific to the uniquely identifiedelectrosurgical delivery device provided from the device tracking andmanagement system.
 3. The system according to claim 2, wherein the readmodule provides information relating to the electrosurgical generator tothe device tracking and management system.
 4. The system according toclaim 3, wherein the device tracking and management system includes abilling module configured to generate a per use bill based on theinformation related to the electrosurgical generator provided by theread module.
 5. The system according to claim 3, wherein the devicetracking and management system includes an inventory control moduleconfigured to maintain product inventory based on the informationrelated to the electrosurgical generator provided by the read module. 6.The system according to claim 1, wherein the readable module includes abar code, and the read module includes a scanner configured to identifythe bar code.
 7. The system according to claim 1, wherein the readablemodule includes a radio frequency identification module and the readmodule includes a scanner configured to identify the radio frequencyidentification module.
 8. The system according to claim 1, wherein thereadable module includes a readable module wireless communication deviceand the read module includes a read module wireless communication deviceconfigured to wirelessly communicate with the readable module wirelesscommunication device.
 9. The system according to claim 1, wherein thereadable module includes memory accessible by the read module when theread module electrically connects to the memory.
 10. A system fortracking use of a medical device, comprising: an electrosurgicalgenerator configured to selectively deliver an electrosurgical energysignal to an electrosurgical delivery device; a packaging systemconfigured to house the electrosurgical delivery device; a packagingreadable module connected to the packaging system and configured touniquely identify the electrosurgical delivery device housed in thepackaging system; and a read module in communication with theelectrosurgical generator and configured to identify the packagingreadable module and further configured to determine the viability of theelectrosurgical delivery device; wherein delivery of the electrosurgicalenergy to the electrosurgical delivery device is enabled by the readmodule if the electrosurgical delivery device is a viable device. 11.The system according to claim 10, wherein the packaging readable moduleis rendered inoperable when the electrosurgical delivery device isremoved from the packaging system.
 12. The system according to claim 11,wherein the packaging readable module is formed between a first layerand a second layer of the packaging system and the packaging readablemodule is rendered inoperable by separating the first and second layers.13. The system according to claim 11, wherein a first layer and a secondlayer of the packaging system form an air-tight seal around thepackaging readable module thereby preventing the packaging readablemodule from exposure to ambient conditions.
 14. The system according toclaim 13, wherein exposure of the packaging readable module to ambientconditions renders the packaging readable module inoperable.
 15. Thesystem according to claim 14, wherein the readable module includes anevaporative material that evaporates when exposed to ambient conditions.16. The system according to claim 14, wherein the readable moduleincludes a readable code and the readable code includes a reactivematerial that modifies the readable code when exposed to ambientconditions.
 17. The system according to claim 11, wherein a firstportion of the packaging readable module is formed on a first layer ofthe packaging material and a second portion of the readable module isformed on a second layer of the packaging material and the packagingreadable module is rendered inoperable by separating the first layer andthe second layers.
 18. The system according to claim 11, furtherincluding: a device tracking and management system in communication withthe read module and configured to provide information specific to theuniquely identified electrosurgical delivery device to the read module,wherein the read module determines the viability of the electrosurgicaldelivery device based on the information specific to the uniquelyidentified electrosurgical delivery device provided from the devicetracking and management system.
 19. The system according to claim 18,wherein the read module provides information relating to theelectrosurgical generator to the device tracking and management system.20. The system according to claim 18, wherein the device tracking andmanagement system includes a billing module configured to generate a peruse bill based on the information related to the electrosurgicalgenerator provided by the read module.
 21. The system according to claim18, wherein the device tracking and management system includes aninventory control module configured to maintain product inventory basedon the information related to the electrosurgical generator provided bythe read module.
 22. The system according to claim 11, wherein thereadable module includes memory accessible by the read module when theread module electrically connects to the memory.
 23. The systemaccording to claim 11, wherein the packaging readable module furtherincludes a readable code and the read module includes a scannerconfigured to identify the readable code.
 24. The system according toclaim 23, wherein the scanner is a camera.
 25. The system according toclaim 11, wherein the packaging readable module includes a radiofrequency identification module and the read module includes a scannerconfigured to identify the radio frequency identification module.
 26. Amethod for enabling delivery of electrosurgical energy to a medicaldevice including the steps of: providing an electrosurgical deliverydevice including a readable module that uniquely identifies theelectrosurgical delivery device; providing a read module thatcommunicates with an electrosurgical generator that selectively deliverselectrosurgical energy to the electrosurgical delivery device;identifying the unique identity of the electrosurgical delivery deviceby reading unique identity information from the readable module with theread module; determining if the electrosurgical delivery device may beused with the electrosurgical generator; and enabling the delivery ofelectrosurgical energy from the electrosurgical generator to theelectrosurgical delivery device if the electrosurgical delivery devicemay be used with the electrosurgical generator.
 27. The method accordingto claim 26, further including the steps of: providing a device trackingand management system in communication with the read module andconfigured to provide information specific to the uniquely identifiedelectrosurgical delivery device to the read module, wherein the readmodule determines the viability of the electrosurgical delivery devicebased on the information specific to the uniquely identifiedelectrosurgical delivery device provided from the device tracking andmanagement system.
 28. The method according to claim 27, furtherincluding the step of: generating a per use bill based on informationrelating to the electrosurgical generator provided by the read module.29. The method according to claim 27, wherein the electrosurgicaldelivery device is a single-use disposable electrosurgical deliverydevice, the method further including the steps of: tracking the usage ofthe single-use disposable electrosurgical delivery device; andpreventing re-use of the single-use disposable electrosurgical deliverydevices if the device tracking and management system indicates a prioruse has occurred.
 30. The method according to claim 27, wherein theelectrosurgical delivery device is a limited-use reusableelectrosurgical delivery device, the method further including the stepsof: tracking the usage of the limited-use reusable electrosurgicaldelivery device, and preventing re-use of the limited-use reusableelectrosurgical delivery device if the device tracking and managementsystem indicates further use is not permissible.
 31. A system fortracking use of a medical device, comprising: an electrosurgicalgenerator configured to selectively deliver an electrosurgical energysignal; an electrosurgical delivery device configured to connect to theelectrosurgical generator and receive electrosurgical energy signaltherefrom; a packaging system configured to house the electrosurgicaldelivery device; and a device readable module connected to theelectrosurgical delivery device and configured to uniquely identify theelectrosurgical delivery device; a packaging readable module connectedto the packaging system and configured to uniquely identify theelectrosurgical delivery device housed in the packaging system; a readmodule in communication with the electrosurgical generator andconfigured to identify the read module, the read module configured toidentify the device readable module and the packaging readable moduleand further configured to determine the viability of the electrosurgicaldelivery device; wherein delivery of the electrosurgical energy to theelectrosurgical delivery device is enabled by the read module if theelectrosurgical delivery device is a viable device.
 32. The systemaccording to claim 31, further including: a device tracking andmanagement system in communication with the read module and configuredto provide information specific to the uniquely identifiedelectrosurgical delivery device to the read module, wherein the readmodule determines the viability of the electrosurgical delivery devicebased on the information specific to the uniquely identifiedelectrosurgical delivery device provided from the device tracking andmanagement system.
 33. The system according to claim 32, wherein theread module provides information relating to the electrosurgicalgenerator to the device tracking and management system.
 34. The systemaccording to claim 33, wherein the read module provides information tothe device tracking and management system that indicates use of theelectrosurgical delivery device.
 35. The system according to claim 32,wherein the device tracking and management system includes a billingmodule configured to generate a per use bill based on the informationrelated to the electrosurgical generator provided by the read module.36. The system according to claim 32, wherein the device tracking andmanagement system includes an inventory control module configured tomaintain product inventory based on the information related to theelectrosurgical generator provided by the read module.
 37. The systemaccording to claim 32, wherein delivery of the electrosurgical energy tothe electrosurgical delivery device is enabled if the device readablemodule and the packaging readable module uniquely identify the sameelectrosurgical deliver device.
 38. The system according to claim 31,wherein one of the device readable module and the packaging readablemodule includes a bar code, the bar code selected from at least one of aone-dimensional bar code and a two-dimensional bar code and the readmodule includes a scanner configured to identify the bar code.
 39. Thesystem according to claim 31, wherein one of the device readable moduleand the packaging readable module includes a radio frequencyidentification module, and wherein the read module includes a scannerconfigured to identify the radio frequency identification module. 40.The system according to claim 31, wherein at least one of the devicereadable module and the packaging readable module includes a readablemodule wireless communication device, and the read module includes aread module wireless communication device configured to wirelesslycommunicate with the readable module wireless communication device. 41.The system according to claim 31, wherein the device readable moduleincludes memory accessible by the read module when the read moduleelectrically connects to the memory.